A clinical study involves treating and following a group of participants to see if a particular therapy is a safe and effective way of treating a specific condition. The FDA (Food and Drug Administration) approves and regulates clinical studies in the United States. ANS, the clinical study’s sponsor, has received FDA approval to conduct this clinical study to evaluate whether the Libra® DBS system suppresses some of the symptoms of Parkinson’s.

ANS is performing this study of its device, the Libra DBS system, for people with advanced levodopa-responsive Parkinson’s that is not adequately controlled by drugs.

The study will be open to approximately 136 participants at approximately 12 centers across the United States.

In addition to having levodopa-responsive Parkinson’s that is no longer adequately controlled by drugs, participants must have been diagnosed with Parkinson’s at least 5 years ago and must be between 18 and 80 years of age. Participants can continue to receive their medications, as needed, while participating in the study.